COVID-19 Update

What’s Next for COVID-19 Vaccines and Variants?

More technologies and treatments are emerging for COVID-19—along with new variants.

Key Elements for Assay Transfer Success

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers.

GMP/GDP Inspection Challenges and Opportunities

An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.

Vaxzevria Gains Approval in EU as a Third Dose COVID-19 Booster in Adults

May 24, 2022

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

Pandemic Science Hub Launches at University of Edinburgh

May 24, 2022

Investment has been made into a new science hub at the University of Edinburgh for the development of treatments for lung infections and future pandemics.

AstraZeneca and RQ Biotechnology Sign License Agreement for Monoclonal Antibodies

May 23, 2022

AstraZeneca has signed a license agreement with RQ Biotechnology for monoclonal antibodies to treat COVID-19.

Pfizer and BioNTech Granted EUA for Booster Dose of COVID-19 Vaccine in Young Children

May 18, 2022

Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.

Pfizer and BioNTech Update COVID-19 Vaccine Supply Agreement with EC

May 18, 2022

The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.

FDA Approves Olumiant (baricitinib) to Treat COVID-19 in Hospitalized Adults

May 11, 2022

The drug is the first immunomodulatory COVID-19 treatment approved by FDA.

FDA Limits Use of Janssen COVID-19 Vaccine

May 06, 2022

FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.

FDA’s Office of Compliance Releases 2021 Annual Report

May 03, 2022

FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.

Moderna Submits EUA of COVID-19 Vaccine for Use in Young Children

May 02, 2022

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

FDA and Industry Prepare for Transition from Emergency Use Authorizations

May 02, 2022

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?